Apotex Recalls Subpotent Leflunomide Tablets Nationwide
Apotex Corp. is recalling specific lots of Leflunomide 10 mg tablets because they did not meet potency specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant product defects like subpotency that may cause adverse health consequences.
Plain-English summary
Apotex Corp. is recalling Leflunomide tablets, 10 mg, manufactured for Apotex Corp. and produced by Apotex Inc. The recall involves 30-count and 1000-count bottles of the prescription medication. The affected lots are GY4197 and GZ1273, both with an expiration date of 11/07.
The recall was initiated because the distributed product was subpotent, meaning it did not meet the required specifications for potency. This is a Class II recall, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- LEFLUNOMIDE (LEFLUNOMIDE)
- Brand
- LEFLUNOMIDE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Prescription Drug
- Affected units
- 3,063
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: a) GY4197
- Exp 11/07
- b) GZ1273
- Exp 11/07.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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